Registration Dossier
Registration Dossier
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EC number: 203-815-1 | CAS number: 110-91-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03. Jan 1967 - 11. Jan 1967
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 967
- Report date:
- 1967
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- Principles of method if other than guideline:
- BASF Test, see details in remarks on material and methods
- GLP compliance:
- no
Test material
- Reference substance name:
- Morpholine
- EC Number:
- 203-815-1
- EC Name:
- Morpholine
- Cas Number:
- 110-91-8
- Molecular formula:
- C4H9NO
- IUPAC Name:
- morpholine
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3.22 and 2.94 kg
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of the same animals served as control.
- Duration of treatment / exposure:
- 1, 5, 15 min or 20 hours
- Observation period:
- 8 days
- Number of animals:
- 2 animals
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): conc. Lutrol and 50 % Lutrol solution
- Time after start of exposure: 1, 5 or 15 min post exposure
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Remarks:
- 1 min exposure
- Basis:
- mean
- Time point:
- other: 8 days
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- overall irritation score
- Remarks:
- 5 and 15 minutes
- Basis:
- mean
- Time point:
- other: 8 days
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritant / corrosive response data:
- The application of the test substance for 1 min caused in 1 animal haemorrhagic areas and leathery-like necrosis at the end of the observation period.
The application for 5 min caused after 24 hours parchment-like necrosis in 1 animal and haemorrhagic areas after 24 hours and leathery-like necrosis after 8 days.
The application of the test substance for 15 min caused haemorrhagic areas, oedema and parchment-like necrosis after 24 hours which declined to leathery-like necrosis after 8 days.
Leathery-like necrosis was considered as a full-thickness necrosis.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
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